FDA.reportPublic FDA data

MAUDE MDR 1773193

MDR report key
1773193
Report number
1221336-2010-00003
Event key
0
Event type
3
Date of event
2010-05-25
Date received
2010-07-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
SANDRA LEE
Address
311 ENTERPRISE DR PLAINSBORO NJ 08536 US
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CABLES, GA275A5.0-90-GCABLESINTEGRA LUXTEC, INC.EQH2A275A50N0UNK* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-07-090

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTS THAT ON "(B)(6) , 2010, A LUXTEC LX300 XENON LIGHT SOURCE, A (B)(6) LUXTEC LIGHT CABLE AND A LUXTEC LIGHTED BREAST RETRACTOR (UNK PN) WERE BEING USED FOR ILLUMINATION DURING A BREAST AUGMENTATION SURGERY. THERE WERE STERILE DRAPES SURROUNDING THE SURGICAL SITE AND UNDER THE DRAPES WAS A WARMING BLANKET. THE LX300 LIGHT SOURCE WAS SET TO ALLOW THE MAXIMUM AMOUNT OF LIGHT INTO THE LIGHT CABLE. AT THE END OF THE PROCEDURE, THE LIGHT SOURCE WAS SWITCHED OFF AND THE LIGHT CABLE WAS REMOVED FROM THE LIGHT SOURCE. THE RETRACTOR WAS REMOVED FROM THE LIGHT CABLE. THE END OF THE LIGHT CABLE THAT CONNECTS TO THE RETRACTOR WAS IMMEDIATELY PLACED ON THE DRAPE (NO TIME ALLOWED FOR THE CABLE TO COOL) AND CAUSED 5 OR 6 SMALL HOLES IN THE DRAPE, JEOPARDIZING THE STERILE FIELD. BECAUSE A BLANKET WAS UNDERNEATH THE DRAPE, NO INJURY OCCURRED."

N

Patient 1

TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.